A Pilot Study to Assess Dry Mouth Relief After Using an Experimental Mouth Rinse

NCT04152642 | Completed Results FDA Device

• 1 other identifier: CSD2019138
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this pilot study is to determine if an experimental mouth rinse and a marketed dry mouth rinse are more effective in relieving dry mouth compared to water.

Conditions

Dry Mouth

Outcome Measures

Primary Outcomes (1)

• Product Performance and Attributes (PPAQ I) Question #1: 2-hr at Day 4

  Product Performance and Attributes (PPAQ I) Question #1: Since you have been used the product, please rate each of the following at this timepoint: (Select one response for each attribute)- excellent=5, very good=4, good=3, fair=2, poor=1: 1\) Relieves the discomfort of your dry mouth

  2-hour, Day 4

Study Arms (3)

Marketed Mouth Rinse

ACTIVE COMPARATOR

dry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 4-hours after first use (on-site) on Day 1 and Day 4.

Device: Marketed Dry Mouth Rinse

Experimental Mouth Rinse

EXPERIMENTAL

dry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 4-hours after first use (on-site) on Day 1 and Day 4.

Device: Experimental Dry Mouth Rinse

Water/Negative Control

SHAM COMPARATOR

subjects will swallow 15 ml of water (on-site). Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 4-hours after water intake (on-site) on Day 1 and Day 4.

Other: Water control

Interventions

Marketed Dry Mouth Rinse DEVICE

relieves dry mouth symptoms by physically coating oral mucosal surfaces.

Marketed Mouth Rinse

Water control OTHER

negative control

Water/Negative Control

Experimental Dry Mouth Rinse DEVICE

relieves dry mouth symptoms by physically coating oral mucosal surfaces.

Experimental Mouth Rinse

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
• Be at least 18 years of age;
• Be in good general health as determined by the Investigator/designee;
• Agree not to participate in any other oral care studies for the duration of this study;
• Agree to delay elective dentistry, including dental prophylaxis, until study completion, and to report any non-study dentistry received during the course of the study;
• Agree to refrain from the use of any non-study oral hygiene products for the study duration including mouth rinse and toothpaste (flossing is permitted if part of their normal routine);
• Self-report a dry mouth feeling according to the modified DMI questions. (Subject must answer at least 2 out of 4 questions with 'agree a little,' 'agree' or 'strongly agree');
• Agree to refrain from smoking, drinking, using tobacco products, using breath mints, medicated lozenges, or chewing gum during the 4-hour test period;
• Agree to return for all scheduled visits and to follow all study procedures.

You may not qualify if:

• Any condition or disease, as determined by the Investigator/Designee, that could be expected to interfere with examination procedures, with compliance, or with the subject's safe completion of the study;
• Severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession;
• Active treatment for periodontitis;
• Having a history of allergies or hypersensitivity to mouth rinse or ingredients in commercial dental products or cosmetics;
• Self-reported pregnancy or the intent to become pregnant during the study, or breast feeding;
• Full or partial dentures or any orthodontic appliances such as braces or aligners, or tongue or mouth piercing;
• Having diabetes;
• Inability to undergo any study procedure;
• Having untreated oral mucosal disease which in the opinion of the investigator could interfere with the study (e.g., current oral ulceration);
• Use of prescription systemic parasympathetic medications (e.g., Pilocarpine), for the treatment of the feeling of dry mouth;
• Currently under the care of a dental/medical professional specifically for the treatment of dry mouth (at the discretion of the Investigator/Designee);
• Self-reported mouth breathers (i.e., mouth breathing secondary to nasal obstruction);
• Evidence of gross intra-oral neglect or need for extensive dental therapy; or
• Currently undergoing radiotherapy and/or chemotherapy treatment.

Sponsors & Collaborators

• Procter and Gamble: lead

Study Sites (1)

Procter & Gamble

Mason, Ohio, 45040, United States

Location

MeSH Terms

Conditions

Xerostomia

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Clinical Trial Manager
• Organization: Procter & Gamble

combs.cs@pg.com

5136225362

Study Officials

• Malgorzata Klukowska, DDS

  Procter and Gamble

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 3-treatment crossover, with 4 days of use

Study Record Dates

• First Submitted: November 1, 2019
• First Posted: November 5, 2019
• Study Start: November 4, 2019
• Primary Completion: December 5, 2019
• Study Completion: December 5, 2019
• Last Updated: February 2, 2021
• Results First Posted: February 2, 2021

Record last verified: 2021-01

Locations

US (1)